A Study to Evaluate the Anti-emetic Effect of Aprepitant Versus Placebo as an Add-on Therapy in Children and Adolescent Receiving Chemotherapy: A Randomized, Doubly Blinded Controlled Trial
Children and adolescents (5-18 years) with weight between 15-65 kg receiving highly
emetogenic chemotherapy (HEC) -
- VAC (vincristine, dactinomycin/Adriamycin, cyclophosphamide)
- ABVD (adriamycin, bleomycin, vinblastine, dacarbazine)
Sampling technique Subjects who met the eligibility criteria will be randomly assigned using
random allocation number generated by computer into one of the two groups. The unit of
randomization will be the subject at first cycle of HEC. The same patient will not be
enrolled for twice
Procedure for data collection:
1. The data will be collected from each patient from d1 to d10 of chemotherapy of which
patient will received chemotherapy in day care, maximum up to d3.
2. After taking consent patient will be enrolled as per inclusion and exclusion criteria,
and randomized to one of two groups. All baseline assessment will be done. Patient will
be explained about the filling of the diary. In first 2 days. The subjects will fill
the diary under the investigator supervision, and the rest of filling will be in home.
Reinforcement will be done over phone.
Procedure of double blinding
- Double blinding will be done for the intervention. Four different boxes will be made
for capsules. Total 3 capsules for 3 days will be made in a blister pack, mentioning
the d1, d2, d3 (for each capsule). Two different body weight groups will be made: 15-40
kg, and 41-65 kg.
- Group "A" will be the code for Aprepitant group and group "B" will be code for control
group. Both patient and the investigator will be blinded regarding medicine in the
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
- Numbers of episodes of nausea and vomiting. - Duration of nausea (in hours). - Severity of nausea as per Edmonton's Symptom Assessment System (ESAS), numerical scale for nausea.
Sameer Bakhshi, MD
Dr. BRA IRCH, AIIMS, New Delhi (India)
India: Indian Council of Medical Research